The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediativ and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the EOS imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:

To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients. The 3D measurement tools interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients, 47 patients with moderate idiopathic scoliosis and 37 patients with scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
To aid in the analysis of lower limbs alignment and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.

Device Description

The sterEOS Workstation is a general system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools.

When used with 2D X-ray images obtained with the EOS imaging's EOS System (K152788), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.

AI/ML Overview

The provided text appears to be a 510(k) summary for the sterEOS Workstation, a medical device for processing X-ray images, and not a study with detailed acceptance criteria and performance data. Therefore, the information requested in the prompt, especially regarding specific acceptance criteria, study methodologies, and quantitative results like sample sizes for test and training sets, number and qualifications of experts, and MRMC study effect sizes, is not present in the provided document.

The document discusses that the device has undergone software verification and validation testing to confirm compliance with specifications, performance, and non-regression. It also states that additional performance and functional testing was performed, and this testing "confirmed the equivalent performance of the modified sterEOS Workstation compared to the predicate sterEOS." However, it does not provide the details of these tests, such as the specific acceptance criteria, the actual performance metrics, or the study methodologies used.

The document states that the new device is "substantially equivalent" to its predicate device (K14137 sterEOS Workstation) due to having the same intended use, similar technological characteristics, and minor differences that do not raise new questions of safety or effectiveness. This suggests that the approval is based on demonstrating equivalence rather than meeting new, specific acceptance criteria through a standalone clinical study detailed in this summary.

Therefore, I cannot populate the table or answer the specific questions because the detailed information about acceptance criteria and the comprehensive study results are not provided in this 510(k) summary.

Here's a summary of what is available related to the request, and what is missing:

The 510(k) summary indicates that the sterEOS Workstation is a software upgrade to an existing device (K14137). The basis for approval is "substantial equivalence" to the predicate.

Missing Information:

Detailed Acceptance Criteria and Performance Data: The summary states "performance data demonstrate that the device is as safe and effective," but it does not provide a table with specific acceptance criteria (e.g., minimum accuracy, precision, sensitivity, specificity for 3D measurements) or the reported device performance against those criteria.
Sample sizes for test set and data provenance: Not mentioned.
Number of experts and qualifications for ground truth: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: Not mentioned. The focus is on demonstrating equivalence to the predicate device.
Standalone performance study: The document refers to "software verification and validation testing" and "additional performance and functional testing" which imply standalone testing, but no detailed results or methodology for such a study (beyond "equivalent performance") are provided.
Type of ground truth used (for performance testing): Not specified.
Sample size for the training set: The "model of bone structures" for spine analysis is derived from an a priori image data set from 175 patients (91 normal, 47 moderate idiopathic scoliosis, 37 severe idiopathic scoliosis) and dry isolated vertebrae data for spine modeling. This 175-patient dataset likely serves as the basis for the model, which could be considered training/development data for the model-based measurements. For lower limbs, it also mentions "a model of bone structures derived from an a priori image data set," but doesn't specify the size or nature of this dataset here.
How ground truth for the training set was established: Not explicitly stated, though for the 175-patient spine data, it implies clinical diagnoses (normal, moderate/severe idiopathic scoliosis).

In conclusion, the provided document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed scientific study report. It states that performance testing confirmed equivalence but does not offer the granular data requested.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2016

EOS Imaging, Inc. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells U.S. L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K160914

Trade/Device Name: sterEOS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 1, 2016 Received: April 1, 2016

Dear Dr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K160914

Device Name

sterEOS Workstation

Indications for Use (Describe)

When using 2D X-ray images obtained with the EOS imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:

To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients. The 3D measurement tools interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients, 47 patients with moderate idiopathic scoliosis and 37 patients with scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
To aid in the analysis of lower limbs alignment and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY EOS imaging, Inc.'s sterEOS Workstation

EOS imaging, Inc. 10 rue Mercoeur PARIS F-75011 FRANCE

Phone: + 33 1 55 25 60 60 Facsimile:

Mathias Breuil, Regulatory Affairs Project Leader Contact Person:

Date Prepared: April 1, 2016

Name of Device and Name/Address of Sponsor:

sterEOS Workstation EOS imaging, Inc. 10 rue Mercoeur PARIS F-75011 FRANCE

Trade Name:	sterEOS Workstation
Common or Usual Name:	Image processing radiological system
Classification Name:	21 C.F.R. 892.2050; Picture archiving and communications systemProduct Code LLZ - system, image processing, radiological
Predicate Device:	510(k) number: K141137Trade/Device Name: sterEOS WorkstationClearance Date: September 15, 2014Regulation Number: 21 CFR 892.2050Regulation Name: Picture archiving and communications systemRegulatory Class: IIProduct Code: LLZ

Device Description

When used with 2D X-ray images obtained with the EOS imaging's EOS System (K152788), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal

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deformities in spine and lower limbs.

Intended Use/ Indications for Use

The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.

When using 2D X-ray images obtained with the EOS imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:

. To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data for spine model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
. To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.

Technological Characteristics

The technological characteristics of the modified sterEOS Workstation are essentially identical to the cleared sterEOS Workstation (K14137). Like the cleared predicate, the subject device is based on the Windows 7 operating system, runs on off-the-shelf hardware, supports DICOM 3.0 formatted images, and has a user interface that follows typical clinical workflow patterns to process, review, and analyze digital images.

The main differences with the cleared sterEOS Workstation consist of the following minor software modifications:

-Addition of information in the User Manual concerning the patient position on X-ray images for the 3D modeling;
। Integration of Patient Database module to improve the sterEOS patient list performances and DICOM functionalities;

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। Simplification of pelvic parameters identification;
-Reorganization of sterEOS 3D module's lower limbs workflows;
-Addition of a new clinical parameter in the global posture workflow;
-Addition of export features to allow for the transfer of sets of data for third-party applications; and
-Various bug corrections.

Minor hardware modifications were also made to enhance usability.

Performance Data

Software modifications have been verified at the unit level. After integration, system software verification and validation testing was performed to ensure compliance with specifications, performance and non-regression. Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS Workstation compared to the predicate sterEOS.

Substantial Equivalence

The device has the same intended use and indications, and very similar technological characteristics and principles of operation, as its predicate device. The minor differences between the device and its predicate raise no different questions of safety or effectiveness. Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS Workstation (K14137) and, thus, is substantially equivalent.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).